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Идёт набор NCT07243002

Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters.

— Наблюдательное Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Breast Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
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Официальное название

Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters: A Hybrid Study With Prospective Patient-reported Outcomes and Retrospective Clinical Chart Review.

Обзор

This non-interventional study (NIS) aims to evaluate effectiveness, persistence, treatment patterns, adverse events (AEs), and patient-reported experience (including adherence, treatment satisfaction, health-related quality of life \[HRQoL\], work productivity, and etc.), among HR+/HER2- stage II and III eBC patients treated with ribociclib + ET, and to evaluate AEs and patients-reported experience among HR+/HER2- stage II and III eBC patients treated with abemaciclib + ET, as per local label.

Подробное описание

This will be a multi-center, multi-country, observational, non-interventional, hybrid study among HR+/HER2- stage II or III eBC patients treated with ribociclib + ET or abemaciclib + ET, as per local label in routine clinical care settings.

The study will include a retrospective and a prospective part. The hybrid design will combine retrospective data extraction from patients' EHRs and prospective data collection from validated PRO questionnaires, bespoke questions, and qualitative interviews, to provide comprehensive data on the patient population.

The exploratory objectives will assess HR+/HER2- stage II and III eBC patients treated with abemaciclib + ET. No formal comparison between the cohorts will be made

Первичные конечные точки

  • Invasive disease-free survival (iDFS) [Срок оценки: 36 months]
  • Distant disease-free survival (DDFS) [Срок оценки: 36 months]
Вторичные конечные точки (12)
  • Adherence to ribociclib + ET assessed using the MARS-5 tool [Срок оценки: Up to approximately 36 months]
  • Adherence to ribociclib + ET assessed using bespoke questions. [Срок оценки: Up to approximately 36 months]
  • Treatment satisfaction with ribociclib + ET assessed using bespoke questions. [Срок оценки: Up to approximately 36 months]
  • Changes in Health Related Quality of Life (HRQoL) with ribociclib + ET assessed using EORTC QLQ-C30. [Срок оценки: Up to approximately 36 months]
  • Changes in Health Related Quality of Life (HRQoL) with ribociclib + ET assessed using EORTC QLQ-BR42. [Срок оценки: Up to approximately 36 months]
  • Changes in Long Term Health Related Quality of Life (HRQoL) with ribociclib + ET assessed using bespoke questions. [Срок оценки: Up to approximately 36 months]
  • Work productivity measured using WPAI [Срок оценки: Up to approximately 36 months]
  • Patients' experience of treatment in HR+/HER2- stage II and III eBC patients treated with ribociclib + ET [Срок оценки: Up to approximately 12 months]
  • Work productivity in HR+/HER2- stage II and III eBC patients treated with ribociclib + ET using bespoke questions. [Срок оценки: Up to approximately 36 months]
  • Persistence to ribociclib + ET [Срок оценки: Up to approximately 36 months]
  • Distant disease-free survival [Срок оценки: At 12, 24 and 36 months]
  • Overall survival [Срок оценки: At 12, 24 and 36 months]

Критерии участия

Критерии включения

  • Males or females.
  • Diagnosed with breast cancer, as defined by the International Classification of Diseases (ICD), 9th or 10th Revision, Clinical Modification (ICD-9-CM 174.xx, 175.xx/ICD-10-CMC50.xx).
  • Aged ≥18 years (or local legal age of consent) at the date of initial breast cancer diagnosis.
  • Patients with anatomic staging II and III as determined using American Joint Committee on Cancer (AJCC) Criteria.
  • Have initiated adjuvant therapy with ribociclib or abemaciclib, per the approved local label, in combination with ET (within 14 days prior to enrollment).
  • Have HR+ status, as determined by the closest biomarker test on or before the adjuvant therapy initiation date:
  • Tested positive for estrogen receptor (ER+), or
  • Tested positive for progesterone receptor (PR+), or
  • Tested positive for both.
  • Tested negative for HER2 (HER2-) using the closest biomarker test on or before the adjuvant therapy initiation date.

Критерии исключения

  • Patients with local or distant breast cancer recurrence before the ribociclib/abemaciclib initiation date.
  • Patients enrolled in clinical trials (receiving treatment with clinical study drugs in any setting, i.e., neoadjuvant, adjuvant, local/regional, metastatic) during the 12-month baseline period.
  • Patients physically/mentally incapable of understanding the study requirements or fulfilling data collection instruments and require the support of a legally authorized representative.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Великобритания · 1 центр
  • Novartis Investigative Site — London

Идентификаторы

NCT: NCT07243002 · CLEE011O12005

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗